Prescription drug · ANDA
Triamterene (Triamterene capsules) NDC 52817-365
Triamterene 100 mg/1 · Capsule · Oral · TRUPHARMA LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 52817-365-10 | 5281703651052817036510 | 100 CAPSULE in 1 BOTTLE (52817-365-10)Marketed from Dec 12, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Triamterene
- Generic name (nonproprietary)
- triamterene capsules
- Active ingredients
- Triamterene — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- TRUPHARMA LLCNDC labeler code 52817
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211581
- Marketing start
- Listing expires
- Other FDA classes
- Decreased Renal K+ Excretion (Physiologic effect)Increased Diuresis (Physiologic effect)
- Identifiers
- Product ID 52817-365_79343fce-fab3-4847-9bd2-09ae1b363827SPL ID 79343fce-fab3-4847-9bd2-09ae1b363827SPL set ID fea50328-b3d5-4300-8c67-82cda0a975b7RxCUI 198312, 198313UNII WS821Z52LQUPC 0352817364104
- Pharmacologic class
- Potassium-sparing Diuretic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N452817036510followed by a unit qualifier and the quantityPackage 52817-0365-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS & USAGE Triamterene Capsules USP is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism. Triamterene Capsules USP may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism. Usage in Pregnancy. The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to…
Excerpt only. Read the full label for complete information.
About NDC 52817-365
- What is NDC 52817-365?
- 52817-365 is the product NDC for Triamterene (triamterene capsules), Triamterene 100 mg/1 capsule, listed with the FDA by TRUPHARMA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Triamterene (Triamterene Capsules).
- What is the active ingredient?
- Triamterene.
- Who is the labeler?
- TRUPHARMA LLC, NDC labeler code 52817. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Triamterene?
- 6 other product NDCs are listed under this name. See all Triamterene NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Triamterene products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Triamterene | Triamterene 50 mg/1 | CapsuleOral | Biocon Pharma Inc. | 70377-138 | 70377-0138-1170377-0138-12 |
| Triamterene | Triamterene 100 mg/1 | CapsuleOral | Biocon Pharma Inc. | 70377-139 | 70377-0139-1170377-0139-12 |
| triamterene | Triamterene 50 mg/1 | CapsuleOral | Prasco Laboratories | 66993-831 | 66993-0831-02 |
| Triamterene | Triamterene 100 mg/1 | CapsuleOral | Prasco Laboratories | 66993-832 | 66993-0832-02 |
| Triamterenetriamterene capsules | Triamterene 50 mg/1 | CapsuleOral | TRUPHARMA LLC | 52817-364 | 52817-0364-10 |
| Triamterenetriamterene capsules | Triamterene 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2265 | 72162-2265-01 |
Other NDCs under ANDA 211581
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Triamterenetriamterene capsules | Triamterene 50 mg/1 | CapsuleOral | TRUPHARMA LLC | 52817-364 |
| Triamterenetriamterene capsules | Triamterene 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2265 |